Legislation

Union legislation

The European Union has adopted a regulatory framework on GMOs to ensure the necessary levels of safety for the environment and human health as provided by the Cartagena Protocol. In the European Union GMOs are authorised for deliberate release into the environment for experimental and commercial purposes only after passing a rigorous risk assessment procedure according to the principles and methodology set out in directive 2001/18/EC (consolidate text 2021), to avoid any possible negative, unintentional or undesirable, direct or indirect, effect on the environment and on human health.
To know more

The Italian competent authority responsible for implementing the provisions of directive 2001/18/EC is the Ministry for Ecological Transition.
  

Italian legislation

Legislative decree 8 July 2003, n. 224 (coordinated text), implementing directive 2001/18/EC, established, in accordance with the precautionary principle, appropriate measures to protect human and animal health and the environment in case of:

• deliberate release of GMOs for purposes other than placing on the market (Title II legislative decree 224/2003);
• placing on the market of GMOs as such or in products (Title III legislative decree 224/2003).
  

To know more

Italian competent authority responsible for implementing the provisions of Legislative decree 8 July 2003, n. 224 is the Ministry for Ecological Transition.

Legislative decree 14 November 2016, n. 227, implementing Directive (EU) 2015/412, which amends Directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) on their territory, has amended Legislative Decree No. 224 of 8 July 2003. It introduced, in Article 35-bis, a mechanism allowing for the restriction or prohibition of GMO cultivation in Italian territory (Title III-bis).

The national competent authority for the implementation of Title III-bis of Legislative Decree No. 224 of 8 July 2003 is the Ministry of Agriculture, Food Sovereignty and Forestry.

To know more.

Pursuant to Article 32 of Legislative Decree No. 224 of 8 July 2003, the Decree of 8 November 2017 was issued, containing the "general plan for surveillance on the deliberate release into the environment of GMOs."

For the sake of completeness, a mention is also made of the legislation concerning the contained use of genetically modified microorganisms (GMMO).

Legislative decree 12 April 2001, n. 206  establishes the measures for the contained use of genetically modified microorganisms, aimed at protecting human health and the environment.
The national competent authority for GMMs is the Ministry of Health.